(165 days)
Not Found
Yes
The summary explicitly mentions and describes the "AiLARA" algorithm, stating it is a "static artificial intelligence (AI) based algorithm" and detailing its training and verification process using training and testing datasets, consistent with machine learning practices.
No.
The device is indicated for taking diagnostic static and serial radiographic exposures of extremities, which implies diagnostic rather than therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use by qualified/trained clinicians... for taking diagnostic static and serial radiographic exposures of extremities." Additionally, the "Device Description" mentions that it is "designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities."
No
The device description explicitly states that the system consists of three major subsystems: The Emitter, Cassette, and Control Unit, which are hardware components. While it includes software with AI capabilities, it is part of a larger hardware system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system used for taking diagnostic static and serial radiographic exposures of extremities. This involves generating X-rays and capturing images of the body, not analyzing samples taken from the body.
- Intended Use: The intended use is for "taking diagnostic static and serial radiographic exposures of extremities," which is a form of medical imaging, not in vitro testing.
- Device Description: The description details components like an Emitter, Cassette, and Control Unit, all consistent with an X-ray system.
- Input Imaging Modality: The input modality is explicitly stated as "X-ray."
The presence of AI for optimizing X-ray parameters and image processing features like adjusting brightness and contrast are all related to the function of an X-ray imaging system, not an in vitro diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
Product codes (comma separated list FDA assigned to the subject device)
IZL
Device Description
The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is intended to interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment. A description of the three major sub-systems is listed below.
- Emitter: This component contains the operator control panel, X-ray tube, and computer vision camera. The control panel allows the operator to control the major functions of the device, including the technique factors. This component is controlled and held in the operator's hand.
- Cassette: This component contains the X-ray detector that collects the X-ray energy and provides a digital representation to the control unit for eventual display. This component also contains status lights and IR lights to assist in X-ray field positioning. The patient anatomy of interest is placed on top of this module.
- Control Unit: This component contains the High Voltage generator, computing power, monitor and keyboard inputs, and other electronics required for the functioning of the device. This module is typically placed on a shelf, cart, counter, or other flat surface convenient to the operator and environment.
The system is intended to work in conjunction with a DICOM monitor, keyboard and a mouse and the mains power outlet.
The Micro C Medical Imaging System, M01 has custom validated software that includes a user interface that allows the operator to view and adjust captured radiographs and transfer radiographs to a PACS server or flash drive.
Mentions image processing
Yes, "Image Processing: User Interface can be used to drag, zoom, rotate and also adjust brightness, contrast, and sharpness."
Mentions AI, DNN, or ML
Yes, "AiLARA is a static artificial intelligence (AI) based algorithm in the updated software." and "Proposed Regulatory Framework for Modifications to Artificial intelligence/Machine Learning (AI/ML) Based Software as a Medical Device (SaMD)(2019)."
Input Imaging Modality
X-ray
Anatomical Site
extremities
Indicated Patient Age Range
Adults and Pediatric
Intended User / Care Setting
qualified/trained clinicians
Description of the training set, sample size, data source, and annotation protocol
AiLARA's full development dataset was split into a training set (80% of the data). AiLARA's model was trained... The model was able to learn the trend of the training dataset (truth).
Description of the test set, sample size, data source, and annotation protocol
AiLARA's full development dataset was split into ...a testing set for algorithm verification (20% of the data) per Good Machine Learning Practices as outlined in FDA's Proposed Regulatory Framework for Modifications to Artificial intelligence/Machine Learning (AI/ML) Based Software as a Medical Device (SaMD)(2019). The full testing set was sent into the model and was predicted to show the model's performance on unseen data. Both training and testing Mean Squared Error and Mean Absolute Error showed that additional training (epochs) would have no added benefit.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- AiLARA Algorithm Verification: The algorithm's performance on unseen data was evaluated using a testing set (20% of the full development dataset). The model learned the trend of the training dataset, and both training and testing Mean Squared Error and Mean Absolute Error indicated no additional benefit from further training.
- Software Verification: Verified that the updated Micro C software met system-level software requirements; all software outputs matched expected results with no anomalies.
- Image Quality Validation Study: A validation dataset was collected with independent inputs (different emitter orientations and angles, various SIDs from 20 cm to 45 cm, multiple orientations) from ankle, elbow, hand, foot, knee, toe, and wrist phantoms. Board certified radiologists and an orthopedic surgeon reviewed and rated the images; all images were determined to be diagnostically and clinically relevant.
- Radiation Dose Testing: AiLARA mode's radiation outputs were evaluated against diagnostic reference levels (DRLs) from literature and compared to the predicate device's manual mode dose outputs. All AiLARA dose values were below established DRLs, and there was no statistical difference between AiLARA and Manual mode calculated entrance skin exposure doses.
- Radiation Dose Testing on Small/Pediatric Anatomies: Evaluated AiLARA's radiation outputs for small size extremity anatomies at different Source to Image Distance (SID) and emitter orientation configurations. All AiLARA dose values were below the established DRLs for small anatomies, and doses were similar within the same target thickness and SID category.
- Usability Evaluation: A study with 15 licensed x-ray technicians with prior x-ray device experience assessed the usability of AiLARA modes. All critical use tasks were completed with a passing result by 100% of participants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean Squared Error, Mean Absolute Error (for AiLARA algorithm verification)
Percentage of participants completing critical use tasks with passing result (for Usability Evaluation)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Micro C Medical Imaging System, M01 (K211473)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
February 4, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of the HHS logo is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
OXOS Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K212654
Trade/Device Name: Micro C Medical Imaging System, M01 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: January 27, 2022 Received: January 28, 2022
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K212654
Device Name Micro C Medical Imaging System, M01
Indications for Use (Describe)
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) |
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3
Section 5 510(k) Summary
Image /page/3/Picture/2 description: The image shows a logo that reads "OXOS MEDICAL". The logo consists of four symbols: a circle with two gaps, an X, another circle with two gaps, and the letter S. The word "MEDICAL" is written in smaller letters below the symbols.
Section 5 510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Micro C Medical Imaging System, M01 Traditional 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Submitter: | OXOS Medical, Inc
1230 Peachtree St NE
Suite #300
Atlanta, GA 30309
Tel: 1-855-SEE-XRAY |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Mo Khosravanipour
Director of Program Management
OXOS Medical, Inc.
Email: Mo@oxos.com
Grace Powers, MS, MBA, RAC
Founder/Principal Consultant
Powers Regulatory Consulting
Email: grace@powersregulatory.com |
| Submission Date: | July 21, 2021 |
| Subject Device: | Trade Name: Micro C Medical Imaging System, M01
Common Name: System, X-Ray, Mobile
Regulation: 21 CFR § 892.1720
Regulatory Classification: 2
Product Code: IZL
Classification Panel: Radiology |
| Predicate Device: | Legally marketed device to which substantial equivalence is claimed:
Micro C Medical Imaging System, M01 (K211473) |
Device Description:
The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is intended to interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The
4
Section 5 510(k) Summary
Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment. A description of the three major sub-systems is listed below.
- Emitter: This component contains the operator control panel, X-ray tube, and computer vision camera. The control panel allows the operator to control the major functions of the device, including the technique factors. This component is controlled and held in the operator's hand.
- Cassette: This component contains the X-ray detector that collects the X-ray energy and provides a digital representation to the control unit for eventual display. This component also contains status lights and IR lights to assist in X-ray field positioning. The patient anatomy of interest is placed on top of this module.
- Control Unit: This component contains the High Voltage generator, computing power, monitor and keyboard inputs, and other electronics required for the functioning of the device. This module is typically placed on a shelf, cart, counter, or other flat surface convenient to the operator and environment.
The system is intended to work in conjunction with a DICOM monitor, keyboard and a mouse and the mains power outlet.
The Micro C Medical Imaging System, M01 has custom validated software that includes a user interface that allows the operator to view and adjust captured radiographs and transfer radiographs to a PACS server or flash drive.
Image /page/4/Figure/8 description: The image shows a white box connected to a handheld device and a square base via cables. Two blue cables connect the box to the handheld device and the square base. Two gray cables also connect the box to the square base.
Figure 5-1: Subject Device - Micro C Medical Imaging System, M01
5
Image /page/5/Figure/2 description: The image shows a computer setup with a monitor, keyboard, mouse, and a white device. The monitor is connected to the white device, and the keyboard and mouse are also connected to it. The white device has several ports on the back, including a power port, USB ports, and an Ethernet port. There are also two wall outlets visible in the image.
Intended Use:
The M01 System is a hand-held X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of extremities.
Indications for Use:
The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult and pediatric patients for taking diagnostic static and serial radiographic exposures of extremities.
The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.
Technological Characteristics
The Micro C Medical Imaging System, M01 is identical to the predicate device cleared via K211473. The purpose of this submission is to update the software to include AiLARA modes as described below. The table below compares the subject and predicate device.
| | Subject Device:
Micro C Medical Imaging
System, M01 | Predicate Device: Micro
C Medical Imaging
System, M01 (K211473) | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | IZL (Mobile X-Ray
System) | IZL (Mobile X-Ray
System) | Identical |
| Regulation | 21 CFR 892.1720 | 21 CFR 892.1720 | Identical |
| Classification
Name | Mobile X-Ray System | Mobile X-Ray System | Identical |
| Classification | Class 2 | Class 2 | Identical |
| Indication for
Use | The Micro C Medical
Imaging System, M01 is a
handheld and portable
general purpose X-ray
system that is indicated
for use by | The Micro C Medical
Imaging System, M01 is
a handheld and
portable general
purpose X-ray system
that is indicated for use | Identical |
| Subject Device:
Micro C Medical Imaging
System, M01 | Predicate Device: Micro
C Medical Imaging
System, M01 (K211473) | Comparison | |
| qualified/trained
clinicians on adult and
pediatric patients for
taking diagnostic static
and serial radiographic
exposures of extremities.
The device is not
intended to replace a
radiographic system that
has both variable tube
current and voltages
(kVp) in the range that
may be required for full
optimization of image
quality and radiation
exposure for different
exam types. | by qualified/trained
clinicians on adult and
pediatric patients for
taking diagnostic static
and serial radiographic
exposures of
extremities.
The device is not
intended to replace a
radiographic system
that has both variable
tube current and
voltages (kVp) in the
range that may be
required for full
optimization of image
quality and radiation
exposure for different
exam types. | | |
| Contraindications | Surgical applicationsPediatric patientsFluoroscopyFor cardiac and vascular applicationsMammographyDental applicationsContact with non-intact skin | Surgical applicationsPediatric patientsFluoroscopyFor cardiac and vascular applicationsMammographyDental applicationsContact with non-intact skin | Identical |
| Age of Device Use | Adults and Pediatric | Adults and Pediatric | Identical |
| Principle of Operation | General purpose diagnostic X-ray | General purpose diagnostic X-ray | Identical |
| Image type produced | Static, serial radiographic
and photographic images
for convenience. | Static, serial
radiographic and
photographic images for
convenience. | Identical |
| Detector | 6 x 6" digital detector | 6 x 6" digital detector | Identical |
| Collimator | The removable fixed
collimators (referred to
as pucks) | The removable fixed
collimators (referred to
as pucks) | Identical |
| Weight | Emitter: 2.86kg (6.3lbs) | Emitter: 2.86kg (6.3lbs) | Identical |
| | Subject Device:
Micro C Medical Imaging
System, M01 | Predicate Device: Micro
C Medical Imaging
System, M01 (K211473) | Comparison |
| Dimension/
Size | Cassette: 6.5kg (14.3lbs)
Control Unit: 8.6kg
(19.0lbs)
Emitter: 9.3"H x 3.5"W x
8.3"L (excluding SSD
Cone)
Cassette: 15.5"H x
15.5"W x 2.8"L
Control Unit: 16.4"H x
12.9"W x 5.5"L | Cassette: 6.5kg (14.3lbs)
Control Unit: 8.6kg
(19.0lbs)
Emitter: 9.3"H x 3.5"W x
8.3"L (excluding SSD
Cone)
Cassette: 15.5"H x
15.5"W x 2.8"L
Control Unit: 16.4"H x
12.9"W x 5.5"L | Identical |
| Triggering
Mechanism | Two stage triggering | Two stage triggering | Identical |
| Minimum
Source to
skin distance
(SSD) | 20 cm SSD Cone ensures
minimum SSD of 20 cm | 20 cm SSD Cone ensures
minimum SSD of 20 cm | Identical |
| Source to
Detector
distance | 20 - 45 cm | 20 - 45 cm | Identical |
| Light Field | Virtual light field on
Monitor UI. No projected
light field. | Virtual light field on
Monitor UI. No
projected light field. | Identical |
| Energy
Source | 120 VAC / 60 Hz (no
rechargeable battery) | 120 VAC / 60 Hz (no
rechargeable battery) | Identical |
| Exposure
Time | 33 ms - 99 ms | 33 ms, 66 ms, 99 ms | Similar- The overall range is
identical. Single AiLARA
mode allows for ms values
throughout the range. Serial
AiLARA mode has a fixed
output of 33 ms. |
| mA | 1.0 mA fixed | 1.0 mA fixed | Identical |
| kVp | 40kVp-60kVp | 40kVp, 50kVp, and
60kVp | Similar- The overall range is
identical. AiLARA allows for
kVp values throughout the
range. |
| Scintillator
Resolution/
Pixel size | Cesium lodide (CsI)
99 μm | Cesium Iodide (Csl)
99 μm | Identical |
| DQE @
0Lp/mm
MTF @ 1
Lp/mm,
RQA5 | 70%
60% | 70%
60% | Identical |
| | Subject Device:
Micro C Medical Imaging
System, M01 | Predicate Device: Micro
C Medical Imaging
System, M01 (K211473) | Comparison |
| Ingress
Protection
Rating | IPOO | IPOO | Identical |
| Image
Processing | User Interface can be
used to drag, zoom,
rotate and also adjust
brightness, contrast, and
sharpness. | User Interface can be
used to drag, zoom,
rotate and also adjust
brightness, contrast,
and sharpness. | Identical |
| Connectivity
Options | WiFi, Ethernet, Four USB
2.0 ports | WiFi, Ethernet, Four
USB 2.0 ports | Identical |
| DICOM | Yes- DICOM 3.0
Compliant | Yes- DICOM 3.0
Compliant | Identical |
| Device
Package
Contents | • Cassette
• Control Unit
• Emitter
• Collimation Pucks
• SSD Cone
• Cassette Power
Cable
• Cassette Data Cable
• Control Unit Power
Cable
• Connector Covers
• Instructions for Use
• Case | • Cassette
• Control Unit
• Emitter
• Collimation Pucks
• SSD Cone
• Cassette Power
Cable
• Cassette Data Cable
• Control Unit Power
Cable
• Connector Covers
• Instructions for Use
• Case | Identical |
Table 5-2: Device Comparison
6
7
8
AiLARA Software
The purpose of this Traditional 510(k) is to update the Micro C Medical Imaging System, M01 software to include two additional modes of use referred to as AiLARA is a static artificial intelligence (AI) based algorithm in the updated software. AiLARA adds two additional modes for the M01 device: Single AiLARA and Serial AiLARA. In these modes, the device determines and recommends a power setting and an exposure time for the X-ray without user input. This mode may help ensure that a clinically relevant image is taken and reduce overexposures and retaking of images.
The Micro C software, including the new AiLARA algorithm, has a Moderate level of concern per with Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005); software developmentation was provided in accordance with the guidance. There was no change to the Micro C software level of concern with the addition of the AiLARA algorithm. The software development lifecycle followed IEC 62304:2015, Medical device software – Software life cycle processes. Risk analysis to address the new algorithm was performed in accordance with ISO 14971:2019, Medical Devices – Application of Risk Management to Medical Devices.
9
Section 5 510(k) Summary
Non-Clinical Performance Data
Testing specific to the Micro C software with AiLARA modes was performed and included with the 510(k) submission:
| Performance Test | Description |
|---|---|
| AiLARA Algorithm | |
| Verification | AiLARA's full development dataset was split into a training set (80% of |
| the data) and a testing set for algorithm verification (20% of the data) | |
| per Good Machine Learning Practices as outlined in FDA's Proposed | |
| Regulatory Framework for Modifications to Artificial | |
| intelligence/Machine Learning (AI/ML) Based Software as a Medical | |
| Device (SaMD)(2019). AiLARA's model was trained, and at the end of | |
| every epoch, the full testing set was sent into the model and was | |
| predicted to show the model's performance on unseen data. The model | |
| was able to learn the trend of the training dataset (truth). The mean | |
| squared error of the training and verification testing datasets were | |
| plotted, and the trend lines showed that the model had learned the | |
| general trend present in the data. Both training and testing Mean | |
| Squared Error and Mean Absolute Error showed that additional training | |
| (epochs) would have no added benefit. | |
| Software Verification | Software verification was performed to ensure the updated Micro C |
| software met system-level software requirements. Software outputs | |
| met the expected result in all cases, with no anomalies found. | |
| Image Quality Validation | |
| Study | An image quality study validation dataset was collected after the |
| AiLARA algorithm was frozen, finalized, and transferred to the Micro C | |
| device. This validation set was completely independent of the algorithm | |
| training and verification testing set. The emitter can move freely in | |
| space (not attached to the detector), therefore the validation images | |
| were collected with independent inputs that the algorithm had not | |
| seen previously. The independent inputs were achieved by taking | |
| images of phantoms at different emitter orientations and angles | |
| (geometries). The validation dataset included images taken from ankle, | |
| elbow, hand, foot, knee, toe, and wrist phantoms; each phantom was | |
| captured at multiple distinct SIDs that spanned the full device SID range | |
| of 20 cm to 45 cm. Additionally, each phantom view/SID combination | |
| was captured at multiple orientations. Once the validation images were | |
| collected, the images were reviewed and rated by board certified | |
| radiologists and an orthopedic surgeon. All images were determined to | |
| be diagnostically and clinically relevant. | |
| Radiation Dose Testing | AiLARA technique and dose evaluation testing was performed to |
| evaluate AiLARA mode's radiation outputs as compared to diagnostic | |
| reference levels from literature, to ensure an acceptable amount of | |
| radiation was delivered. Additionally, AiLARA's dose outputs from the | |
| auto-selected techniques were compared to the predicate device's | |
| manual mode dose outputs that result from the techniques | |
| recommended in the Instructions for Use. Results showed that all | |
| AiLARA dose values were below the established Diagnostic Reference | |
| Radiation Dose Testing on | |
| Small/Pediatric Anatomies | Levels (DRLs) and there was no statistical difference between AiLARA and Manual mode calculated entrance skin exposure doses. |
| Testing was conducted to evaluate AiLARA's radiation outputs for small size extremity anatomies (representing low thicknesses seen for small patients, especially pediatrics) as compared to diagnostic reference levels from literature to ensure an acceptable amount of radiation was delivered. This study also included recording dose outputs at different Source to Image Distance (SID) and emitter orientation configurations to ensure doses are consistently acceptable at various emitter orientations and small anatomy thicknesses. Results showed that all AiLARA dose values were below the established Diagnostic Reference Levels (DRLs) for small size anatomies, and doses were similar among captures for each orientation within the same target thickness and SID category. | |
| Usability Evaluation | A usability evaluation was performed for the addition of the AiLARA modes for single radiography and serial radiography (DDR) imaging to ensure the Micro C Medical Imaging System, M01 has acceptable use-related risks and effectiveness during use. The study included 15 participants who were licensed to perform x-ray procedures and had previous experience operating x-ray devices. All the identified critical use tasks were completed with a passing result by 100% of participants. The usability evaluation was performed in accordance with IEC 62366-1:2020, Medical devices - Part 1: Application of usability engineering to medical devices and Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices (2016) |
Table 5-3: Non-Clinical Performance Data
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In addition, the following specific FDA guidance documents were utilized in the device development to ensure the safety of this device for both the operators and patients:
- Guidance for Medical X-ray Imaging Devices Conformance with IEC Standards (2019) ●
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (2016)
- Radiation Safety Considerations for X-ray Equipment Designed for Hand-held Use (2008)
- Pediatric Information for X-ray Imaging Device Premarket Notifications (2017)
Clinical Performance Data
Non-clinical data generated using imaging phantoms representative of the intended patient populations was sufficient to support the updates to the Micro C device software; no clinical studies were performed. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusion
The Micro C Medical Imaging System, M01 is identical in physical design to the legally marketed predicate device. The updated software is acceptable as demonstrated by the performance data and does not raise different questions of safety and effectiveness.